DelfaGLP-1 Atlas

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CompletedPhase 2Results posted

Role of Exenatide in Type 1 Diabetes

The Role of Exenatide in Type 1 Diabetes Mellitus

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

11

actual

Study population

Type 1 diabetes

Key I/E criterion

•HbA1c ≤8.5%

Primary endpoint

•Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00456300
Org study IDH-16488

Timeline

Milestones

Study first posted2007-04-04estimated
Last update posted2019-02-26actual
Results first posted2019-02-26actual
Study start2007-03actual (month precision)
Primary completion2009-03actual (month precision)
Study completion2009-03actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age12 Years
Maximum age21 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

***Subjects must be patients of the Texas Children's Hospital Diabetes Care Center***.

All of the following criteria must be met:

1. Between 12-21 years of age at the time of enrollment.

2. Have been diagnosed with Type 1 diabetes for at least 1 year and in good control (HbA1C less than 8.5%).

3. Subjects must be otherwise healthy except for the Type 1 Diabetes and treated hypothyroidism.

4. Menstruating women must have a negative pregnancy test.

5. Hemoglobin equal to or greater than 12 g/dL before each study.

6. Weight greater than 44 kg.

7. Tanner stage greater than 3

Exclusion criteria

1. Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism; stable on medications.

2. Lack of a supportive family environment as detected by the clinicians and/or social workers.

3. Positive pregnancy test in menstruating young women.

4. BMI greater than 90th percentile for age or less than 10th percentile for age.

5. Lactating and nursing mothers.

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Mean Plasma Glucose Area Under the Curve (AUC) for Blood Glucose Concentration in the Exenatide 1.25 mcg or Exenatide 2.5 mcg Treated Groups Along With Insulin, Compared to Insulin Alone

Time frame:0-120 minutes post-dose

concentration, improvement

Posted result

GroupValue (mean), mmol*L/min95% CI
Exenatide 1.25 mcg + Insulin49—
Exenatide 2.5 mcg + Insulin44—
Insulin Monotherapy379—

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.